Does Minimally Invasive Surgery Reduce Anxiety?

Sponsor
Zeynep Kamil Maternity and Pediatric Research and Training Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02938845
Collaborator
(none)
74
1
2
47
1.6

Study Details

Study Description

Brief Summary

The purpose of this study was to identify factors that may contribute to anxiety of patients undergoing total abdominal hysterectomy(TAH) or total laparoscopic hysterectomy(TLH) before and after the operation. Thus, we aimed to learn whether anxiety levels change according to the type of hysterectomy.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI )
  • Procedure: total laparoscopic hysterectomy(TLH)
  • Procedure: total abdominal hysterectomy(TAH)
N/A

Detailed Description

Hysterectomy is the most common gynecological procedure worldwide. . There has been a increasing interest towards to more minimally invasive procedures in the past decade. Hysterectomy operation anxiety is a complex phenomenon affected by various parameters. Patients' anxiety may be affected by their age, gender, educational status,type of operation and personality. Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Factors Related to Patients' Anxiety Before and After Hysterectomy
Study Start Date :
Jan 1, 2013
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: total laparoscopic hysterectomy(TLH)

Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI )
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.

Procedure: total laparoscopic hysterectomy(TLH)

Experimental: total abdominal hysterectomy(TAH)

Each patient's anxiety was measured using Spielberger's State-Trait Anxiety Inventory immediately before, immediately after the operation.

Behavioral: Spielberger's State-Trait Anxiety Inventory(STAI )
State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.

Procedure: total abdominal hysterectomy(TAH)

Outcome Measures

Primary Outcome Measures

  1. STAI-S's Inventory [change from immediately before operation to immediately after the operation.]

  2. STAI-T's Inventory [change from immediately before operation to immediately after the operation.]

Eligibility Criteria

Criteria

Ages Eligible for Study:
35 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

undergone hysterectomies for benign reasons.

Exclusion Criteria:

malignancy, additional operation beside hysterectomy( such as salpingo-oophorectomy), history of two or more previous caesarean sections, history of previous abdominal surgery, autoimmune disease, coagulation disorders, with known systemic or psychiatric disease, those receiving any regular sedative medication at the time of the procedure

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zeynep Kamil Woman and Child Diseases Education and Research Hospital Istanbul Turkey 34000

Sponsors and Collaborators

  • Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ahmet Eser, medical doctor, Zeynep Kamil Maternity and Pediatric Research and Training Hospital
ClinicalTrials.gov Identifier:
NCT02938845
Other Study ID Numbers:
  • 025
First Posted:
Oct 19, 2016
Last Update Posted:
Dec 8, 2016
Last Verified:
Dec 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2016